FDA Knew About Potentially Lethal Diabetes Drug Since Last August, Said Nothing

The Type 2 diabetes drug Avandia may have caused heart attacks in “tens of thousands of people,” according to a study by the Cleveland Clinic. The study showed that patients on Avandia had a 43% higher risk of heart attacks, and a 64% increase in cardiovascular death. The maker of the drug, GlaxoSmithKline, separately told the FDA of the risk last August, but neither the drug maker nor the Agency warned the public.

The study was outed yesterday on the New England Journal of Medicine’s website. The editors of the journal and the study’s lead author both warned that the research methodology left the “findings open to interpretation.”

Even though the FDA was aware of the risks since last summer,

…the publication of the study on the journal’s Web site prompted the Food and Drug Administration to issue a public safety alert and advise users of the drug — an estimated million people in this country and two million worldwide — to consult their doctors about the potential cardiovascular risks.

Congress wants to know why the FDA can’t walk and chew gum, after the jump…

The FDA is trying to defend itself against comparisons to its handling of Vioxx by pointing out that it is almost done with its own independent review of the study. That isn’t enough for several members of Congress.

The House Energy and Commerce Committee has already asked why the Agency couldn’t warn the public while the study was underway. Congressman Henry Waxman, Chair of the House Committee on Oversight and Government Reform, plans to haul the head of the FDA, Andrew von Eschenbach, before his committee for questioning.

Patients on Avandia may want to call their doctor. — CAREY GREENBERG-BERGER

Heart Attack Risk Seen in Drug for Diabetes [NYT]
Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes [New England Journal of Medicine]

Comments

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  1. timmus says:

    Congress wants to know why the FDA can’t walk and chew gum

    Uhh… because pharmaceutical executives often go to work for the FDA, and FDA executives often go to work on pharmaceutical boards? The fox has been in the henhouse a long time.

  2. Imhotep says:

    Criminal. When profits are put ahead of patient care, there will be casualties, and a lack of oversight; but only always. Time for some reckoning, and a new agency or system that’s not tied into the profits of these drug dealers.

  3. MBPharmD says:

    And if you read the study (I know, heaven forbid), the increased risk of death from cardiovascular cause was NOT statistically significant (OR 1.64, 95%CI 0.98-2.74, p=0.06) so there is NO increased risk of death. Anybody who doesn’t have their head in their arse knows these drugs (thiazolidinediones) increase edema, especially in patients with heart failure, and in fact are contraindicated in patients with NYHA Class III or IV heart failure. If you exclude those patients who would never be on these drugs in 2007 (but were in the early 2000s) the risk would be much smaller, if not eliminated completely.

    Did the FDA screw up? Probably. But just believing the media hype on this one is just as ignorant as those you call out.

  4. crayonshinobi says:

    @timmus: Not to mention the collusion with members of congress as well.

    I’ve been waiting for FDA approval of an eye surgery for years now.(They’ve been doing them in Europe for more than a decade). It was about to get approved and then congress and the house changed ownership last election and suddenly the procedure was pushed back to the initial stages of testing…I guess they didn’t grease the new palms.

  5. CaptainConsumer says:

    I was just getting over another 4 hour erection and now this?

  6. virgilstar says:

    I’m with MBPharmD on this one. It is a minor problem, compared to the epidemic of diabetes that is raging in this country and will account for half of all deaths by mid century. There were some early pointers in that another drug in this same class (troglitazone) was withdrawn by the FDA a few years ago, so its not entirely surprising that this one is now probably going the same route. Once a fundamental mechanism underlying a side effect has been worked out, it’s usually curtains for the entire class, not just one compound.

  7. Red_Eye says:

    @Imhotep: LOL oh the irony in your comment. Are you aware when someone screws up a code blue event in a hospital and the outcome may be brain death or damage but they have brought the patient back from the grave there is often a peer review meeting. In this meeting the code is discussed as well as whether it would cost the hospitals insurance company more to keep a person alive if they are in a vegitatitve state for the next 20 years or to encourage pulling the plug and settling out of a lawsuit? Oh and since its a ‘peer’ review its covered by confidentiality laws in many states so its not even admissible in court.